Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; povidone; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - zytiga is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - capecitabine, quantity: 500 mg - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide red; lactose monohydrate; magnesium stearate; hypromellose; microcrystalline cellulose; purified talc; croscarmellose sodium - colon cancer,capecitabine sandoz is indicated for the adjuvant treatment of patients with dukes' stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine sandoz is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine sandoz is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine sandoz in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - valaciclovir hydrochloride, quantity: 556.275 mg (equivalent: valaciclovir, qty 500 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of ophthalmic zoster. for the treatment of recurrent herpes labialis (cold sores) for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes. reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see section 4.4 special warnings and precautions for use). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; iron oxide yellow; hypromellose; titanium dioxide; copovidone; arginine; maize starch; purified talc; magnesium stearate; propylene glycol - trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. trajentamet is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea. trajentamet is indicated in combination with an sglt2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an sglt2 inhibitor. trajentamet is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; iron oxide yellow; propylene glycol; copovidone; colloidal anhydrous silica; arginine; maize starch; purified talc; magnesium stearate; titanium dioxide - trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin.,trajentamet is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.,trajentamet is indicated in combination with an sglt2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an sglt2 inhibitor.,trajentamet is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.

Australia - English - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - valaciclovir hydrochloride hydrate, quantity: 556.275 mg (equivalent: valaciclovir, qty 500 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of ophthalmic zoster. for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of >15ml/min. prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; povidone; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).